09957451 (B.P.A.I. Jun. 11, 2012)

Ex Parte Schurr et al

Board of Patent Appeals and InterferencesJun 11, 2012

09957451 (B.P.A.I. Jun. 11, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 09/957,451 09/21/2001 Marc O. Schurr 06530.0276-00000 2507 22852 7590 06/12/2012 FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001-4413 EXAMINER EREZO, DARWIN P ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 06/12/2012 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________________ Ex parte MARC O. SCHURR, KURT A.E. GEITZ, and ROBERT SAKAL ____________________ Appeal 2010-005258 Application 09/957,451 Technology Center 3700 ____________________ Before: PHILLIP J. KAUFFMAN, EDWARD A. BROWN, and CHARLES N. GREENHUT, Administrative Patent Judges. GREENHUT, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-005258 Application 09/957,451 2 STATEMENT OF CASE Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1, 2, 5, 7, 120, 121, 124, 126, 127, 129-132, 134, 135, 137, 138, 140, 142-145, 147, 148, 150-155, 157, 164-167, 173-175, and 177-181. App. Br. 7. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. The claims are directed to devices for folding and securing tissue. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A device for securing a fold of tissue in a medical procedure, the device comprising: a first arm; a second arm disposed substantially opposite to the first arm and having a first end fixedly connected to a first end of the first arm to define an opening to receive the fold of tissue, wherein the first and second arms are configured to extend in substantially the same direction as the fold of tissue and secure to the tissue fold with the arms remaining exterior to an outer surface of the tissue fold, and said opening being configured to allow tissue to extend from said connection beyond a second end of each of the first and second arms when the tissue is secured, the second ends of the first and second arms being located opposite the first ends of the first and second arms, wherein the second end of the first arm is configured to maintain a non-contacting relationship with the second end of the second arm when the device is in a final tissue-fold-securing position, the second end of each of the first and second arms including a distalmost surface of the respective arm that is furthest from the first end of the respective arm, wherein the second end of the first arm is configured to maintain a non-contacting relationship with the second end of the second arm when the device is in an initial, normal position; wherein the first and second arms are comprised of a bioabsorbable material such that the first and second arms are capable of disintegrating in a body; and Appeal 2010-005258 Application 09/957,451 3 at least one of the first and second arms including an integral anchoring portion protruding from at least one of the first and second arms and configured to maintain a non-contacting relationship with the other of the first and second arms when the device is in the final tissue-fold-securing position, wherein the other of the first and second arms does not include a structure for receiving the integral anchoring portion. REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Beaty Le Roy Larkin Yoon US 3,032,039 US 3,604,425 US 4,246,903 US 5,620,452 May 1, 1962 Sep. 14, 1971 Jan. 27, 1981 Apr. 15, 1997 REJECTIONS Claims 1, 2, 5, 7, 120, 121, 124, 126, 127, 129-131, 134, 135, 137, 138, 140, 142-144, 147, 148, 150-154, 157, 164-167, 174, 178, 180, and 1811 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Le Roy and Yoon. Ans. 4. Claims 132, 145, 155, 173, 175, 177, and 179 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Le Roy, Yoon, and Beaty. Ans. 8. 1 Claims 172 and 176 have been cancelled. Advisory Action mailed Feb. 6, 2009. Appeal 2010-005258 Application 09/957,451 4 OPINION The rejection of claims 1, 2, 5, 7,120, 121, 124, 126, 127, 131, 134, 135, 137, 138, 140, 144, 147, 148, 150-152, 154, 157, 164-167, 180, and 181 is sustained. Claims 1, 2, 5, 7, 120, 121, 124, 126, 127, 131, 134, 135, 137, 138, 140, 144, 147, 148, 150-152, 154, 157, 164-167, 180, and 181 are argued as a group. We select claim 1 as representative under 37 C.F.R. § 41.37(c)(1)(vii). The Examiner correctly found, and Appellants do not dispute, that Le Roy discloses the basic device of claim 1. However, Appellants contend that since Le Roy’s clip is designed for external wounds, there would have been no reason to modify it with the bioabsorbable material of Yoon as proposed by the Examiner. App. Br. 23. The portions of Le Roy relied upon by Appellants in support of the assertion that Le Roy’s clip is designed for external use are Le Roy’s discussions that the clip is particularly effective with scalp and back wounds, and of losing the clip within the body. App. Br. 23-24. However, neither of these discussions supports the notion that Le Roy’s clip is confined to external use. The stated purpose of Le Roy is preventing blood flow from arteries, capillaries, and the like—vessels that reside within the body. See Col. 1, ll. 11-13, col. 2, ll. 36-37. Procedures involving the back and scalp do not necessarily refer to external procedures. Further, a statement that the device is particularly effective in a certain area would not be understood by one of ordinary skill in the art as confining the device for use in that area. Medical devices may be considered to have been “lost” inside the body whether the procedure was external or not. “Lost” simply means not in a known area. Appeal 2010-005258 Application 09/957,451 5 Appellants further contend that the fact that Le Roy’s clip is designed to be easily and rapidly removable teaches away from making it bioabsorbable. App. Br. 24. We disagree. The fact that Le Roy’s clip is easily and rapidly removable does not relate to how long the clip is in place. It suggests the desirability of not leaving it in place permanently. Making the clip bioabsorbable is another way to achieve this same end. We do not find anything in Le Roy suggesting the desirability of mechanical removal specifically, as opposed to by a chemical or biological process. Yoon demonstrates it was known in the art to use a bioabsorbable material on clips having a structure (fig. 1) and function (figs. 2-6) similar to that of Le Roy, constricting anatomical vessels (col. 1, ll. 8-9). Thus, we agree with the Examiner that the claimed subject matter involves the application of a known technique to improve upon a known device in order to yield the predictable result of obviating the need to mechanically remove the clip during the initial hemostatic or a subsequent surgical procedure, and therefore would have been obvious to one having ordinary skill in the art. Ans. 6. The rejection of claims 129, 142, 174, and 178 is reversed. [I]t is the examiner's position that the tapered tip portion 34 of Le Roy is fully capable of piercing tissue when enough force is applied to the clip. For example, a pen has a rounded or blunt tip, but it can also be used to penetrate a skin surface when enough force is applied. Ans. 9-10. First, Le Roy does not disclose or suggest any resemblance of the rounded ends 34, the structure interpreted by the Examiner as an additional anchor, to a pen. Thus, the alleged skin-piercing capabilities of a pen are of little probative value. Appellants correctly point out that rounded ends 34 Appeal 2010-005258 Application 09/957,451 6 appear to be designed to specifically avoid tissue damage and pain. App. Br. 26 (citing Le Roy col. 2, ll. 60-63), 29. This suggests it would be particularly difficult to use Le Roy’s rounded ends to pierce2, as opposed to crush a tissue fold. Thus, the Examiner has not demonstrated a sound reasonable basis for the belief that Le Roy’s rounded ends are capable of piercing a tissue fold. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990); Ex parte Skinner 2 USPQ2d 1788, 1789 (BPAI 1986). Accordingly, we cannot agree with the Examiner that one of ordinary skill in the art would understand “an additional anchoring portion including one of a pin, bolt, suture, staple, and rod configured to pierce the tissue fold” as including Le Roy’s rounded ends. The rejection of claims 130, 143, and 153 is reversed. The Examiner has provided an edited, marked up version of Le Roy’s figure 5 in an effort to demonstrate “the tip portion 34 includes a tapering portion that tapers away from the gap.” Ans. 7, 10. As the Examiner provides no further explanation, it appears the Examiner has misread the claim language which requires “the distal end of one of the first and second arms includes a tapering portion curving away from the gap.” First, if the ends of Le Roy’s arms 34 were regarded as curving, it would likely be in the direction, as Le Roy describes it, “toward the slit.” In any case, the tapered portions of Le Roy do not appear to be curving (cf. crook 306 in Application Fig. 6) at all and the Examiner does not appear to have addressed this limitation. 2 See pierce in Chambers 21st Century Dictionary (2001) retrieved from http://www.credoreference.com/entry/chambdict/pierce Appeal 2010-005258 Application 09/957,451 7 The rejection of claims 132, 145, 155, 173, 175, 177, and 179 is sustained. Claims 132, 145, 155, 173, 175, 177, and 179 are argued as a group and we select claim 132 as representative under 37 C.F.R. § 41.37(c)(1)(vii). Appellants contend the Examiner’s proposed modification of Le Roy to relocate Le Roy’s projections 18 to the distal end of the clip as taught by Beaty is improper because such a modification would defeat the intended purpose of Le Roy, modify Le Roy’s principle of operation, and require a different applicator than the one taught by Le Roy. App. Br. 31-34. These arguments are not persuasive. Providing projections 18 in a particular location is not a fair characterization of the intended purpose or principal of operation of Le Roy. Le Roy aims to provide an easy way to open and close a spring biased hemostatic clip by causing the leg sections 24 of that clip to pivot about a bridging section 26. One of ordinary skill in the art would recognize that the specific location of the projections that cause the legs to pivot is not critical to this operation since this same result can be achieved with the projections provided at other locations, such as the opposite side of the pivot point. See e.g., Beaty figs. 6-7. The only operational change this would involve is a change in the location the applicator contacts the clip and pulling the legs outwardly as opposed to pushing them inwardly (see arrows on applicator 14 in Le Roy fig. 1) to effectuate opening. Beaty teaches a spring-biased clamp that is structurally similar, and operates in a manner similar to Le Roy, by being forced open by an applicator and then allowed to close, to achieve essentially the same result, closing an artery or vein. See Beaty col. 1, ll. 42- 45, col. 2, ll. 6-21. Beaty also demonstrates an applicator suitable for use Appeal 2010-005258 Application 09/957,451 8 with the modification as proposed by the Examiner was known in the art3. See Beaty figs. 5-7. While the applicator must be specific to the clip or clamp, essentially the same process and same result could be achieved whether the applicator is designed to open the clip by pulling it outwardly on the open, distal end of the pivot, or pushing it inwardly on the opposite, proximal end. Thus, we cannot agree with Appellants that a modification of the specific location of the projections or the specific applicator used would defeat the intended purpose of Le Roy’s clip or change its principal of operation. DECISION The rejection of claims 1, 2, 5, 7,120, 121, 124, 126, 127, 131, 134, 135, 137, 138, 140, 144, 147, 148, 150-152, 154, 157, 164-167, 180, and 181 is sustained. The rejection of claims 129, 142, 174 and 178 is reversed. The rejection of claims 130, 143, and 153 is reversed. The rejection of claims 132, 145, 155, 173, 175, 177, and 179 is sustained. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART hh 3 Le Roy’s prior applicator described in US 3,446,212 (iss. May 27, 1969)(col. 1, ll. 6-8) also seems suitable for this purpose.